Lower Urinary Tract Symptoms Clinical Trial
Official title:
Comparing the Usability of an Electronic Bladder Diary and a Paper Bladder Diary: a Two-way Crossover Study
This piece of research is a single centre, two-way cross over, prospective study to compare
the outcomes and experience of patients completing a paper bladder diary and an electronic
version. This project aims to examine whether an electronic bladder diary can improve data
quality compared to a paper bladder diary. Participants will attend an introduction
appointment within the Urology Department at Royal Hallamshire Hospital. The participant will
complete the bladder diaries at home and will then complete a questionnaire at the Royal
Hallamshire Hospital.
Patients who are being sent an appointment for urodynamics (standard or video) will be also
sent a recruitment letter and participant information sheet (PIS), to inform them of the
study. One week later a member of the study team will phone the patient, to see if they are
interested in participating in the study and assess the eligibility criteria. If that patient
is interested and they fulfil the inclusion/exclusion criteria they will be invited to attend
an introduction appointment. This will be conducted 1-2 weeks prior to the urodynamic test,
at which point study details will be discussed and written informed consent will be taken.
The participant will be taught how to use the digital and paper versions of the bladder
diaries
Participants will be asked to complete the electronic diary for three days and the paper
diary for three days. Half of the participants will complete the digital diary first, the
other half will complete the paper diary first, and this will be done by alternating
consecutively. Patients will be asked to record the time and volume of voids, any
incontinence or urgency episodes and sleep-wake times. On the day of their urodynamics
appointment, patients should return with their electronic and paper diaries
Micturition time-charts, frequency-volume charts and bladder diaries are inexpensive,
non-invasive tools that allow the assessment of lower urinary tract symptoms (Konstantinidis
et al. 2011); with a large proportion of women giving them low burden scores (Vella et al.
2012).
A micturition time chart records 'the times of micturitions, day and night, for at least 24
hours' (Abrams et al. 2002), whereas frequency-volume charts record 'the volumes voided as
well as the time of each micturition, day and night, for at least 24 hours' (Abrams et al.
2002) and a bladder diary 'records the times of micturitions and voided volumes, incontinence
episodes, pad usage and other information such as fluid intake, the degree of urgency and the
degree of incontinence' (Abrams et al. 2002). However, the three terms are often used
interchangeably in the literature, purely meaning documentation of void time, volume and +/-
urgency.
Frequency-volume charts are used to record patients' symptoms before and after therapeutic
interventions and in bladder training, to assess the success of the treatment (Abrams and
Klevmark, 1996).
NICE (2013) states that men with bothersome lower urinary tract symptoms should complete a
urinary frequency-volume chart as part of their initial assessment. They provide information
on: daytime frequency, nocturia, 24-hour frequency, 24-hour production, polyuria, nocturnal
urine volume, nocturnal polyuria and maximum voided volume (Abrams et al. 2002).
Frequency-volume charts can help to distinguish between nocturnal polyuria and detrusor
overactivity by assessing the volume of urine voided (NICE, 2013).
Frequency-volume charts provide an insight in a patient's voiding patterns in their own
environment and during their usual daily activities (Konstantinidis et al. 2011). A high
test-retest reliability been shown for frequency-volume charts (Jimenez-Cidre et al. 2015;
Yap et al. 2007), demonstrating their dependability.
The use of a frequency-volume chart can reduce recall error (Locker et al. 2001), as when
retrospectively assessed >50% of patients overestimated daytime frequency in comparison to
their frequency-volume chart (Stav et al. 2009).
Electronic diaries have been trailed in other areas of healthcare, most with success.
Electronic diaries used to monitor asthma symptoms (Jiang et al. 2009), pain (Stone et al.
2003), headaches (Allena et al. 2012), amongst others showed to have a higher compliance
compared to paper diaries.
Stone et al. (2003) compared the completion of a paper and electronic pain diary. The paper
diary was fitted with a hidden device to track the opening and closing of the binder, to help
monitor completion. It was found that on 32% of study days the paper diary was not opened,
yet the compliance for these days was >90%. This suggests there has been backfilling of data,
questioning the reliability of the data. This is further confirmed by Gaertner et al. (2004)
who demonstrated more retrospective fabrication of data in the paper diary.
Broderick (2008) suggested that the time taken for data analysis is significantly reduced
when using an electronic diary compared to a paper diary. However, the time for software
installation and training should be taken into consideration.
A pain monitoring study showed that electronic diaries had a higher rate of compliance and
less back dating of information (Stone et al. 2003).
Despite a number of patients lacking experience in the use of computers, patient satisfaction
was higher for the electronic diary in a number of studies (Gaertner et al. 2004; Broderick,
2008), with many saying it was easy to understand and to use (Allena et al. 2012)
This is a single centre, two-way cross over, prospective study to compare the outcomes and
experience of patients completing a paper bladder diary and an electronic
version.Participants will attend an introduction appointment within the Urology Department at
Royal Hallamshire Hospital. The room will ensure privacy for the patient. The participant
will complete the bladder diaries at home. The participant will complete the questionnaire at
the Royal Hallamshire hospital, in private.Participants will be asked to complete the
electronic diary for three days and the paper diary for three days. Half of the participants
will complete the digital diary first, the other half will complete the paper diary first,
and this will be done by alternating consecutively.
Patients will be asked to record the time and volume of voids, any incontinence or urgency
episodes and sleep-wake times. Patients return one week later with their electronic and paper
diaries. Patients will be asked to complete a short questionnaire regarding their opinions.
Clinicians should analyse the data as usual. Introduction and follow-up appointments will try
to be arranged around patients' hospital appointments to avoid additional visits. Patients
will be provided with an ELAROS electronic bladder diary as the electronic diary.
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